This invention relates to intravascular catheters, and more particularly to balloon-tipped catheters and to a novel method of use to control hemorrhage during surgery.
Minimally invasive or video-assisted surgical procedures are being rapidly developed as a method of replacing conventional surgery. These new techniques reduce surgically-induced complications and subsequently, the medical costs associated with long hospital stays. Current minimally invasive surgical techniques include laparoscopic, endoluminal, perivisceral, endoscopic, thoracoscopic, intra-articular and hybrid approaches. As an illustration of this procedure, access into a body cavity, e.g., peritoneal or pleural cavity, is made through a small incision. The cavity may be insuffilated with gas, such as carbon dioxide or saline fluid to provide a working space, if necessary, as is commonly done for laparoscopic or intra-articular procedures, in which case the gas or fluid is injected through an insufflation needle. After removing the needle, surgical instruments may be inserted at the incision into the cavity or working space, and an endoscopic camera is inserted through the opening into the cavity. Under direct visualization, additional incisions are then made at strategic locations in the body for inserting secondary surgical instruments to perform the operation.
Despite the significant advances in minimally invasive techniques, serious complications may arise due to accidental cutting or perforation of vessel or organ. As an illustration, the application of these techniques to pulmonary resections, particularly lobectomy or partial lobectomy, has been limited by the fear that the pulmonary artery is relatively inaccessible, so that hemorrhage, if it occurs, cannot be easily stopped in a closed chest. Currently, the routinely used method of controlling hemorrhage in a closed space is to apply a clip or staple to the injured vessel. This would be a difficult undertaking once hemorrhage commences due to the lack of visibility at the operative site in a closed cavity.
Therefore, a need exists for an effective manner of stopping vascular flow into an operative site during a minimally invasive surgical procedure, particularly in thoracoscopic applications.
The use of balloon-tipped catheters which are flow-directed to the pulmonary artery for measuring right-sided vascular pressures was first described in 1953 (Lategola, M. and Rahn, H. (1953) Proc. Soc. Exp. Biol. Med. 84: 667-68). Since then, pulmonary artery balloon catheters have been widely used for monitoring vascular pressures in the fields of anesthesia and critical care medicine. In 1970, Swan, Ganz and associates reported the use of a flow-directed catheter in humans and further refined it for direct measurement of pulmonary capillary wedge pressure (Swan et al. (1970) N Engl J Med 283: 447-51). At present, this catheter is an invaluable aid in the management of critically ill patients with pulmonary and cardiac disease. Moreover, pulmonary wedge pressure (as an estimation of left ventricular filling pressure or preload) is the standard of reference for intravascular volume management.
In addition to monitoring right heart pressures, balloon-tipped catheters, particularly flow-directed Swan-Ganz catheters have been routinely used for sampling mixed venous blood, and for infusing solutions. Numerous variations of these catheters are available in configurations containing double and triple lumens, as described in U.S. Pat. Nos. 3,746,003, 3,833,004, 3,710,781, 3,634,924, 3,152,592, 3,044,468, 3,050,066 and 2,845,930 and elsewhere.
Balloon-tipped catheters are generally inserted under pressure waveform monitoring, with or without fluoroscopic control. Typically, the catheter may be inserted into a patient at the bedside into a median basilic or deep brachial vein by a cutdown, or it may be inserted percutaneously through the subclavian, internal jugular or femoral vein. After insertion, the balloon on the catheter tip is carried by the stream of maximal blood flow through the right atrium and right ventricle into the branch of the right pulmonary artery and, with a lesser frequency, into the left pulmonary artery. Variations on the ultimate location of the catheter depend mainly on the position of the patient when the catheter is inserted (Parlow, J. L. (1992), J. Cardiothoracic and Vascular Anesthesia 6(1):20-23), but surgeons also develop their own movements for steering to a desired site.
A primary objective of the present invention is to provide a modified balloon-tipped flow-directed catheter useful for stopping the blood flow in the event of injury to a vessel during minimally invasive surgery.
If such a catheter could be dependably and quickly deployed in a determined position by a vessel branch point, it could be used intraoperatively to provide emergency hemostasis.
It is thus an object of the invention to provide a balloon catheter that is readily deployed during endoscopic surgery at a site effective to occlude a vessel supplying the site of surgery.
It is a further object to provide a method of quickly and efficiently deploying such balloon, and method of stopping hemorrhage with the balloon.
It is also an object of the invention to provide a balloon-tipped catheter containing a light fiber positioned in the balloon assembly which emits light in the vicinity of the balloon.
Another object is to provide a method of controlling hemorrhage during minimally invasive surgery, such as thoracic surgery, wherein the balloon catheter of the present invention is inserted into the pulmonary artery on the side of the lung to be operated on and the exact location of the balloon is determined by direct visual or video observation of emitted light. In the event of injury to the vessel during surgery, the balloon is inflated to stop the blood flow.
It is more generally an object of the invention to provide an endovascular catheter and a method of positioning the catheter during surgery.